Optical Coherence Tomography (OCT) Imaging of Post Coil Aneurysm Healing. - Tabular View

Tracking Information

First Received Date ^ICMJE

November 7, 2007

Last Updated Date

March 13, 2009

Start Date ^ICMJE

January 2007

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00556309 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Optical Coherence Tomography (OCT) Imaging of Post Coil Aneurysm Healing.

Official Title ^ICMJE

Optical Coherence Tomography (OCT) Imaging of Post Coil Aneurysm Healing.

Brief Summary

At Beckman Laser Institute, University of California, Irvine, we have developed diagnostic device call 'Optical Coherence tomography (OCT).'

OCT is an imaging technique capable of performing high-resolution,cross-sectional imaging. OCT enables real-time, in situ visualization of tissue microstructure without the need to excise and process the specimen as required for conventional biopsy and histopathology.

OCT is analogous to ultrasound except that imaging is performed with light instead of acoustic waves. OCT measures light reflected from turbid structures. Consequently, OCT is a powerful method to image biological tissue in-vivo at high resolution.

The objective of the study is to demonstrate a healing response in coiled aneurysms using OCT imaging at three months. The healing process constitutes fibrosis, and organization of the coiled aneurysm as well as re-endothelization.

Detailed Description

Subjects presenting with subarachnoid hemorrhage secondary to ruptured cerebral aneurysms as well as subjects with unruptured aneurysms that are being treated using endovascular coiling will be included in the study.

An image will be acquired by the Optical Coherence Tomography (OCT) at the time of initial angiography in subjects with unruptured aneurysms, and at the three month follow up catheter angiogram for all subjects. Patients with acutely ruptured aneurysms will not be investigated with OCT at the initial intervention. Images obtained at three month follow up will be analyzed for aneurysm healing based on the presence of a membranous covering or endothelization.

Endovascular therapeutic coiling is a widely used procedure in the management of aneurysms, which is an angiogram . Following therapeutic coiling of the aneurysm the 6F endocatheter and the microcatheter used for the coiling procedure will be left in place in the internal carotid artery and parent artery lumen respectively. The OCT fiber will be inserted through the lumen of the tube on which the images will be obtained.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Prospective

Condition ^ICMJE

Aneurysm

Intervention ^ICMJE

Device: OCT

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age ≥ 18 years of age
Subject diagnosis of aneurysm and undergoing endovascular coiling

Exclusion Criteria:

Pregnant women
Age ≤ 18 years of age
Patient presenting emergently with acutely ruptured aneurysms

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00556309

Responsible Party

Mark E Linskey, MD, UCIMC

Study ID Numbers ^ICMJE

NIH-OCT EB-093-07, LAMMP MET RR-01192-29

Study Sponsor ^ICMJE

University of California, Irvine

Collaborators ^ICMJE

Beckman Laser Institute University of California Irvine

Investigators ^ICMJE

Principal Investigator:

Mark E Linskey, MD

UCIMC

Information Provided By

University of California, Irvine

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP